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Use for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries.

JMS SysLoc MINI™ A.V. Fistula & JMS SysLoc MINI™ Apheresis Needle Set is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharps safety features as described in 21 CFR 876.5540. Just like the predicate device, JMS SysLoc MINI™ A.V. Fistula Needle Set & JMS SysLoc MINIT™ Apheresis Needle Set comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards. JMS SysLoc MINI™ A.V. Fistula Needle Set & JMS SysLoc MINI™ Apheresis Needle Set included in this 510(k) is a modification from the legally marketed device. JMS SysLoc® A.V. Fistula Needle Set & JMS SysLoc® Apheresis Needle Set. The SysLoc MINI™, is a 'mini' version of the predicate device (JMS SysLoc®) with modification made to reduce the overall length, so that the device is more user/patient friendly. Modifications are done accordinaly to the other components such as wing and hub in order to realize the intended device.

The provided text is a 510(k) summary and FDA clearance letter for a medical device (JMS SysLoc MINI AVF Needle Set and JMS SysLoc MINI Apheresis Needle Set). This type of document is for regulatory clearance based on substantial equivalence to a predicate device, not typically for reporting on a study demonstrating specific device performance against defined acceptance criteria in the way a clinical trial or a performance study for a diagnostic AI device would.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI or diagnostic device cannot be extracted from this document because it pertains to a different type of device and regulatory submission.

The document states that "Bench testing was conducted to verify that the SysLoc MINI™ device is performing as intended to be a safe and effective medical device, data and reports are enclosed within this submission document." However, the details of these bench tests, including specific acceptance criteria and detailed performance metrics, are not provided in the publicly available summary (the pages provided). This type of information would typically be in the full submission, not the summary given here.

In summary, the provided document does not contain the information required to populate the table and answer the detailed questions about acceptance criteria and study design for statistical performance metrics.

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